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Suspension Syndrome

Primary Purpose

Circulatory Collapse, Circulatory Failure, Syncope, Vasovagal, Neurally-Mediated

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Suspension in a harness
Climbing
Sponsored by
Institute of Mountain Emergency Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Circulatory Collapse

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteers
  • Age 18-50 years
  • ASA class 1
  • Signed informed consent

Exclusion Criteria:

  • Age <18 or >50 years
  • ASA class >1
  • Informed consent not signed

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Suspension without prior climbing

    Suspension with prior climbing

    Arm Description

    Free Suspension in a harness after baseline measurements and without prior climbing

    Free Suspension in a harness after baseline measurements and after climbing in moderate intensity for 10 minutes

    Outcomes

    Primary Outcome Measures

    Heart rate
    Blood pressure

    Secondary Outcome Measures

    Change in maximal Diameter of superficial femoral vein
    Ultrasound measurement of the Diameter of the superficial femoral vein in millimeters
    Change in interbeat-interval
    electrocardiographic measurement of interbeat interval in milliseconds (ms)

    Full Information

    First Posted
    March 15, 2016
    Last Updated
    April 5, 2016
    Sponsor
    Institute of Mountain Emergency Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02726776
    Brief Title
    Suspension Syndrome
    Official Title
    Suspension Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institute of Mountain Emergency Medicine

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Suspension syndrome refers to a potentially life-threatening condition that can occur in unconscious persons after prolonged suspension in a harness. To date, our understanding of the pathophysiology and appropriate treatment is based primarily on case reports and expert opinion. The main pathophysiological hypothesis implicates blood pooling in the lower extremity and lack of return via muscle pumping. However, a recent French study could not support this hypothesis. Other mechanisms, such as a central vagal reflex may play a role in the pathophysiology of suspension syndrome. The aim of this study is to better understand the pathophysiological basis of suspension syndrome and to develop practical recommendations for prevention and treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Circulatory Collapse, Circulatory Failure, Syncope, Vasovagal, Neurally-Mediated, Orthostatic Hypotension

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Suspension without prior climbing
    Arm Type
    Experimental
    Arm Description
    Free Suspension in a harness after baseline measurements and without prior climbing
    Arm Title
    Suspension with prior climbing
    Arm Type
    Experimental
    Arm Description
    Free Suspension in a harness after baseline measurements and after climbing in moderate intensity for 10 minutes
    Intervention Type
    Other
    Intervention Name(s)
    Suspension in a harness
    Intervention Type
    Other
    Intervention Name(s)
    Climbing
    Primary Outcome Measure Information:
    Title
    Heart rate
    Time Frame
    Change from baseline (measurement at minute 0) -> suspension phase (minute 10, timepoint immediately before interruption of suspension phase [max 60 minutes]) -> minute 5 and minute 15 after suspension phase
    Title
    Blood pressure
    Time Frame
    Change from baseline (measurement at minute 0) -> suspension phase (minute 10, timepoint immediately before interruption of suspension phase [max 60 minutes]) -> minute 5 and minute 15 after suspension phase
    Secondary Outcome Measure Information:
    Title
    Change in maximal Diameter of superficial femoral vein
    Description
    Ultrasound measurement of the Diameter of the superficial femoral vein in millimeters
    Time Frame
    Change from baseline (measurement at minute 0) -> suspension phase (minute 10, timepoint immediately before interruption of suspension phase [max 60 minutes]) -> minute 5 and minute 15 after suspension phase
    Title
    Change in interbeat-interval
    Description
    electrocardiographic measurement of interbeat interval in milliseconds (ms)
    Time Frame
    Change from baseline (measurement at minute 0) -> suspension phase (minute 10, timepoint immediately before interruption of suspension phase [max 60 minutes]) -> minute 5 and minute 15 after suspension phase

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy volunteers Age 18-50 years ASA class 1 Signed informed consent Exclusion Criteria: Age <18 or >50 years ASA class >1 Informed consent not signed
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Peter Paal, MD, MBA
    Organizational Affiliation
    Barts Heart Centre, London
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Hermann Brugger, MD
    Organizational Affiliation
    Eurac, Institute of mountain emergency medicine
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    21420883
    Citation
    Pasquier M, Yersin B, Vallotton L, Carron PN. Clinical update: suspension trauma. Wilderness Environ Med. 2011 Jun;22(2):167-71. doi: 10.1016/j.wem.2010.12.006. Epub 2010 Dec 23.
    Results Reference
    result
    PubMed Identifier
    17384373
    Citation
    Lee C, Porter KM. Suspension trauma. Emerg Med J. 2007 Apr;24(4):237-8. doi: 10.1136/emj.2007.046391.
    Results Reference
    result
    Available IPD and Supporting Information:
    Available IPD/Information Type
    Study Protocol
    Available IPD/Information URL
    https://cloud.scientificnet.org/index.php/s/7vKbCJ1vs0UOYNN
    Available IPD/Information Comments
    Unfortunately available only in German
    Available IPD/Information Type
    Informed Consent Form
    Available IPD/Information URL
    https://cloud.scientificnet.org/index.php/s/9RXyWhRxEgUgbTd
    Available IPD/Information Comments
    Unfortunately available only in German or Italian

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    Suspension Syndrome

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